As recently as the early 1990s, surgical operations for trauma were directed at the anatomic repair of all injuries at time of the initial operation. It was observed during these exercises that many patients became hypothermic, acidotic, and coagulopathic. Patients showing these three signs often died. Death often occurred in the operating room due to exsanguination, or postoperatively, due to the complications of prolonged shock and massive transfusion to replace blood lost as a result of the trauma.
One of the most notable developments in the recent evolution of surgery has been the introduction of the concept of staged laparotomy to overcome the deficiencies of the repair all-at-once approach. This new strategy of staged laparotomy employing new tactics that have been termed “Damage Control” is now used in 10% to 20% of all trauma laparotomies. During damage control procedures, time is of the essence. Every minute that passes without hemostatic control, leads to further blood loss, shock and risk of intra-operative exsanguination. In damage control operations it is important to contain or stop, as quickly as possible, hemorrhage from major wounds to the blood vessels. Additionally, it is important to quickly stop spillage from body ducts and lumens such as the bile duct.
Devices and methods of control for hemorrhage from solid organs, viscera, body ducts, and vasculature are desirable in order to minimize damage to the patient as a result of the trauma. Typical vascular injuries requiring hemostatic control may include, for example, a wound to the descending abdominal aorta, the iliac arteries and veins, superior mesenteric vessels, vena cava or the portal vein, renal arteries and veins, superficial femoral artery, popliteal artery, ulnar arteries and lumbar arteries. The existing methods for controlling these include clamping and sewing, or compressing the vessel until ischemia occurs. All these current methods have the potential for tissue necrosis as they do not permit blood flow to continue through the wounded vessel once hemorrhage has been stopped.
Although there are procedures for controlling these injuries, their use has been hampered due to the lack of utilization of optimal devices or tactics in their execution. Each area offers technological opportunities to improve the devices and procedures for applying those devices. While existing methods and procedures, including the use of standard vascular instruments, vascular clamps, sutures, and tourniquets do allow the rapid control of vascular and visceral injuries in many cases, the standard techniques and tools have not been designed for temporary placement as part of a staged operation. Specifically, tourniquets, forceps, vessel clamps or clips can lead to tissue necrosis due to ischemia, and sutures take a long time to apply and are generally not appropriate in a damage control or emergency setting. Vascular shunts such as the Javid shunt and the Argyle shunt exist but are not suitable for emergency application on the hemorrhaging patient. They are primarily intended for use in carotid procedures. New devices, procedures and methods are needed to support the strategy of damage control in patients who have experienced vascular injury. Such devices and procedures are particularly important in the emergency, military, and trauma care setting. These limitations have been overcome by the new device and method described below.